Newborn Screening Market| Coherent Market Insights

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2. NEWBORN SCREENING MARKET ANALYSIS Newborn Screening Market, by Product Type (Assay Kits, Hearing Screening Devices, Mass Spectrometer, and Pulse Oximetry), by Application (Blood Spot Disease, Critical Congenital Cardiac Disease, Maple Syrup Urine Disease, Hearing Disability, Sickle Cell Disease, and Thyroid Disorder), by Test (Blood Test, Cardiac Test, Hearing Test, and Urine Test), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Trends, and Forecast to 2026

3. Newborn screening describes various tests that are performed during first few hours or days of an infant’s life. These tests have the potential for preventing severe health problems, including death. Newborn screening has evolved from a simple urine or blood screening test to a more comprehensive and complex screening system capable of detecting over 50 different conditions. Newborn screening tests measure a number of markers in infant’s blood that can be either decreased or increased if an infant has certain diseases. Currently, conditions such as cystic fibrosis (CF), congenital hypothyroidism, phenylketonuria (PKU), and around 22 other metabolic conditions that affect protein or fat metabolism can be diagnosed through newborn screening tests. The global newborn screening market size was valued at US$ 561.5 million in 2018, and is expected to witness a CAGR of 12.4% over the forecast period (2018 – 2026).

4. Global Newborn Screening Market Share (%) Analysis, By Product 2018

5. Increasing government support for newborn screening and developments in screening technologies is expected to drive the newborn screening market growth Several governments are taking initiative in increasing awareness about newborn screening tests and are offering free screening services in some regions. For instance, in September 2018, the Florida Department of Health launched the Newborn Screening (NBS) Web Order Application. This statewide initiative has been developed to ensure efficiency and accuracy of newborn screening information submitted to the Bureau of Public Health Laboratories. Moreover, novel biomarkers and analytical technologies are driving the evolution of Newborn Screening (NBS) programs. For instance, a rapid and highly sensitive point-of-care testing device has been developed and commercialized for the diagnosis of Sickle Cell Disease (SCD). According to a BMC Medicine Journal study 2015, SCD test demonstrated 99% specificity and 99% sensitivity for the diagnosis of several hemoglobin (Hb) variants: sickle cell trait (Hb AS), sickle cell anemia (Hb SS), Hb AA, Hb AC, and Hb SC, and requires only 5 μL of blood. Similarly, Next-Generation Sequencing (NGS) technologies are expected to impact newborn screening in the near future.

6. Newborn Screening Market Restraints However, lack of consensus for screening is a major restraining factor for newborn screening market growth. There is little agreement among countries on which specific disorders should be included in NBS programs. Although some countries screen for only one Inherited Metabolic Disorders (IMD), others screen for over 30 conditions. For instance, according to the Nature Medicine Journal 2012 study, screening strategies in Europe vary between countries. Moreover, in some countries such as Belgium, Italy, and Spain, policy-making is decentralized to regions or provinces that have separate NBS programs. Similar conditions are observed in the U.S. where one state may result in screening a different set of disorders compared to a neighboring state. This absence of agreement on screening tests is due to the lack of high-quality observational evidence for most disorders. Furthermore, multiple challenges need to be confronted including false negative and false positive results of screening tests, inadequate information about the natural history of disease, limited access in some geographic areas to advanced technologies, and treatment of conditions with various phenotypes.

7. Global New Born Screening Test Market Value (US$ Mn) & Y-o-Y Growth (%)

8. New Born Screening Test Market - Regional Insights On the basis of region, the global newborn screening market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. By 2026, North America and Europe are expected to generate major revenue share in the global newborn screening market, owing to the presence of a better reimbursement structure, development of well-equipped healthcare infrastructure, and availability of trained medical professionals. According to the U.S. government, for the 2018 fiscal year, the Newborn Screening Quality Assurance Program at the CDC is funded at US$ 8.4 million and the Heritable Disorders program at Health Resources and Services Administration (HRSA) is funded at $13.88 million. The most common newborn screening tests in the U.S. include, hypothyrodism, galactosemia, PKU (phenylketonuria), and sickle cell disease. Increasing government funding in Europe for NBS within a national health service or a statutory health insurance, is expected to drive newborn screening market growth in Europe. Key players operating in the global newborn screening market include, Agilent Technologies, AB SCIEX, Bio-Rad Laboratories, Covidien PLC, GE Life Sciences, Masimo Corporation, Natus Medical Inc., PerkinElmer Inc., and ZenTech S.A.

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